Risk-Analysis Tools in Process Validation of Biopharmaceutical Drugs - The authors outline different risk-assessment tools to evaluate the crucial factors and parameters affecting product quality, pot

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Risk-Analysis Tools in Process Validation of Biopharmaceutical Drugs
The authors outline different risk-assessment tools to evaluate the crucial factors and parameters affecting product quality, potential failure points, and the probablity of occurrence for each unit.


BioPharm International
Volume 24, Issue 3, pp. 44-48

TEAM SELECTION FOR RISK ASSESSMENT


Table 1
Risk management is a team-based approach fostering collaboration from a cross-functional team. Therefore, selection of people in this team is crucial for the success of the exercise. Teams should include individuals skilled in process development, manufacturing, validation, quality control, product characterization, method development, and quality assurance.

RISK-ANALYSIS TOOLS

The various types of risk that pharmaceutical companies confront include patient risk (i.e, safety of drugs), operational risk (i.e., operation safety and process variability), product-quality risk (i.e., endotoxin, viruses, host cell proteins, host cell DNA, protein ligands, refolding agents, and process additives), financial risk (i.e., product loss, reputation, and legal costs), and regulatory risk (i.e., FDA Form 483s, Warning Letters, product recalls, seizures, and legal actions) (3). An appropriate risk analysis can minimize process risk.


Figure 1. A Fault-Tree Analysis for production of mAbs. (Figures courtesy of the authors)
The various tools available for risk analysis are fault-tree analysis (FTA), failure-mode-effect analysis (FMEA), Ishikawa diagrams, hazard analysis, and criticalcontrol point (HACCP). In the report, Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals, expert committee members of the World Health Organization discuss FTA and FMEA in detail (4).


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